What the label lists and what reports show
Lapine t-lymphocyte immune globulin side effects
Lapine t-lymphocyte immune globulin's FDA label: “The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the …” FAERS holds 8,019 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (678 reports).
- No generic listed
Check it at the source: the lapine t-lymphocyte immune globulin FDA label on DailyMed (effective June 24, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, low counts of platelets and white blood cells.
Table 6: Adverse Reactions Treatment-emergent adverse events that occurred during or within 24 hours of an infusion are summarized. Occurring within 24 Hours of Infusion and with >5% Incidence in THYMOGLOBULIN Patients
| Adverse Reaction | THYMOGLOBULIN (N=82) | Active Comparator ATG-E (N=81) |
|---|---|---|
| Chills | 45 (55%) | 28 (35%) |
| Leukopenia | 40 (49%) | 10 (12%) |
| Fever | 38 (46%) | 39 (48%) |
| Nausea | 24 (29%) | 17 (21%) |
| Thrombocytopenia | 24 (29%) | 30 (37%) |
| Headache | 22 (27%) | 22 (27%) |
| Hypertension | 22 (27%) | 16 (20%) |
| Pain | 21 (26%) | 19 (24%) |
| Tachycardia | 19 (23%) | 16 (20%) |
| Diarrhea | 16 (20%) | 15 (19%) |
| Peripheral edema | 16 (20%) | 13 (16%) |
| Vomiting | 16 (20%) | 12 (15%) |
| Abdominal pain | 14 (17%) | 13 (16%) |
| Hyperkalemia | 14 (17%) | 12 (15%) |
| Arthralgia | 12 (15%) | 11 (14%) |
| Constipation | 12 (15%) | 16 (20%) |
| Dyspnea | 12 (15%) | 11 (14%) |
| Asthenia | 11 (13%) | 11 (14%) |
| Leukocytosis | 11 (13%) | 9 (11%) |
| Anemia | 10 (12%) | 11 (14%) |
| Back pain | 10 (12%) | 8 (10%) |
| Hypokalemia | 10 (12%) | 7 (9%) |
| Insomnia | 10 (12%) | 4 (5%) |
| Lung disorder | 10 (12%) | 6 (7%) |
| Myalgia | 9 (11%) | 7 (9%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, low counts of platelets and white blood cells. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions and laboratory abnormalities (incidence >5% higher than comparator) are urinary tract infection, abdominal pain, hypertension, nausea, shortness of breath, fever, headache, anxiety, chills, increased potassium levels in the blood, and low counts of platelets and white blood cells. Prophylaxis of Acute Rejection The safety of THYMOGLOBULIN compared to Active Comparator for the prophylaxis of acute rejection in patients receiving a kidney transplant were evaluated in a randomized, open-label, international, multicenter trial in patients receiving solitary kidneys from deceased donors (n=278; Study 1).
Source: FDA drug label, Genzyme Corporation, effective June 24, 2026 (SPL set bbd8ab99-552e-4b81-aca4-6b0c7af8b9ae), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,019 reports list lapine t-lymphocyte immune globulin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,038 are coded as a death and 2,960 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lapine t-lymphocyte immune globulin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions